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The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
For more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard cap | Active Comparator | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. |
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| 0.3mm XPF cap | Experimental | Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. |
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| 0.5mm XPF cap | Experimental | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5mm XPF cap | Device | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Attenuation in Percentage (%) | The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100. | 1 day |
| Absolute Radiation Exposure Outside of Cap | The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Operator Comfort Assessment | After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). | 1 day per participant, a total of 197 operator days |
| Operator Comfort Assessment Based on Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul Herrera, MD | Baptist Hospital of Miami, Miami Cardiac and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami, Miami Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25982649 | Result | Uthoff H, Quesada R, Roberts JS, Baumann F, Schernthaner M, Zaremski L, Hajirawala L, Katzen BT, Staub D, Kreusch AS. Radioprotective lightweight caps in the interventional cardiology setting: a randomised controlled trial (PROTECT). EuroIntervention. 2015 May;11(1):53-9. doi: 10.4244/EIJV11I1A9. |
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Voluntary patient participation. PI responsible for patient selection.
Patients presenting to the Miami Cardiac and Vascular Institute for Imaging Study/Procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Cap | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. |
| FG001 | 0.3mm XPF Cap | Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. 0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. |
| FG002 | 0.5mm XPF Cap | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. 0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Cap | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. |
| BG001 | 0.3mm XPF Cap |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiation Attenuation in Percentage (%) | The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100. | Mean Radiation Protection is described under Outcome Measure Data below. | Posted | Mean | 95% Confidence Interval | Percentage | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Cap | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raul Herrera, MD. Director Miami Cardiac and Vascular Institute, Research and Outcomes | Baptist Health South Florida | 786-596-3505 | raulh@baptisthealth.net |
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| 0.3mm XPF cap | Device | Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. |
|
| Standard cap | Device | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. |
|
After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). |
| 1 day per participant, a total of 197 operator days |
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
| BG002 | 0.5mm XPF Cap | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. 0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
| OG001 | 0.3mm XPF Cap | Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. 0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. |
| OG002 | 0.5mm XPF Cap | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. 0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. |
|
|
| Primary | Absolute Radiation Exposure Outside of Cap | The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured. | The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms. | Posted | Mean | 95% Confidence Interval | uSv | 1 day |
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| Secondary | Operator Comfort Assessment | After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). | Posted | Mean | Full Range | score on a scale | 1 day per participant, a total of 197 operator days |
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| Secondary | Operator Comfort Assessment Based on Weight | After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). | Posted | Mean | Full Range | grams | 1 day per participant, a total of 197 operator days |
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| 59 |
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| 59 |
| EG001 | 0.3mm XPF Cap | Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. 0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG002 | 0.5mm XPF Cap | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. 0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | 0 | 64 | 0 | 64 | 0 | 64 |
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